Overview

Antimicrobial Adjuvants to Revert the Imbalance of Skin Microbiota for Improved Outcomes of Complicated Cutaneous Leishmaniasis Treatment in Ethiopia

Status:
NOT_YET_RECRUITING

Trial end date:
2027-04-01

Target enrollment:

Participant gender:

Summary

This clinical trial aims to evaluate the effectiveness of combining the standard treatment for complicated cutaneous leishmaniasis (CL), sodium stibogluconate (SSG), with either topical fusidic acid 2% cream or a vehicle cream without active ingredient. The goal is to assess whether this combination improves treatment outcomes by restoring the balance of the skin microbiome (dysbiosis) in patients with severe CL, a condition common in Ethiopia. The study will compare three treatment groups: * Fusidic Acid Group: SSG plus topical fusidic acid for 2 weeks. * Vehicle Cream Group: SSG plus topical vehicle cream for 2 weeks. * Control Group: SSG only, with no topical treatment. The primary objective is to determine if the addition of fusidic acid improves treatment outcomes compared to SSG alone, as measured by substantial improvement in the index lesion at the end of treatment (EoT). A total of 180 patients will be enrolled at two hospitals in Ethiopia. The trial will run for 24 months, with a focus on understanding how restoring the skin microbiome can improve CL treatment outcomes and potentially provide a low-cost, accessible treatment strategy for CL patients.

Phase:

PHASE3

Details

Lead Sponsor:

Institute of Tropical Medicine, Belgium

Collaborators:

Arba Minch University
Armauer Hansen Research Institute (AHRI), Ethiopia

Treatments:

Fusidic Acid